FDAFDA · Food and drugs·Recall number Z-0561-2015
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
Published December 17, 2014 · Recall initiated: October 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pfm Medical Inc
- Distributor
- Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
- Lot
- Lot No. 1307-024, 1302-031, 1210-015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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